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NCT04952753 · ClinicalTrials.gov registry record · Phase 2
Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 204
- Enrollment target
NCT04952753: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04952753 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 204 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04952753, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 204 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC. This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.
Primary Outcome
Percentage of participants with DLTs during the first cycle of treatment. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness or concomitant medication that occurs within the first cycle of treatment with NIS793 with or without tislelizumab in combination with Bevacizumab and modified FOLFOX6/ FOLFIRI and meets protocol defined DLT criteria.
Interventions
- DRUG Bevacizumab
- DRUG Tislelizumab
- DRUG FOLFIRI
- DRUG Modified FOLFOX6
- DRUG NIS793
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2025-01-20 |
| Phase | Phase 2 |
Why NCT04952753 stopped before completion
NCT04952753 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT04952753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04952753 about?
NCT04952753 is a clinical study titled "Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC". The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC. This study aims to explore whether different mechanis...
What is the current status of trial NCT04952753?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2021-11-15. Estimated completion is 2025-01-20.
What interventions are being tested in trial NCT04952753?
The interventions under investigation include: Bevacizumab (DRUG), Tislelizumab (DRUG), FOLFIRI (DRUG), Modified FOLFOX6 (DRUG), NIS793 (DRUG).
Who is sponsoring clinical trial NCT04952753?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04952753's enrollment target sits among peer trials
204 299th of 2000 higher than 1,700 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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